BEUDAMED
    FDA Registration Active 🇺🇸 United States

    XS-1000i sampler (OPSU-11)

    Reg #: 3020704087 · FEI: 3020704087 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    42
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sysmex America, Inc. - Vernon Hills
    Registration Number
    3020704087
    FEI Number
    3020704087
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1011 Woodlands Parkway
    City
    Vernon Hills
    State
    IL
    ZIP
    60061
    Country
    US

    Owner / Operator

    Firm Name
    SYSMEX CORPORATION
    Operator Number
    9014170
    Address
    4-4-4 TAKATSUKADAI, NISHI-KU
    City
    KOBE
    State
    JP-NOTA
    Postal Code
    651-2271
    Country
    JP

    Products

    Device Name Product Code
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG

    Proprietary Names

    XS-1000i sampler (OPSU-11) ST-41 HST-N RU-10 CV-60 AlphaN-XESU TS-10 Barcode Terminal (BT-40) ST-40 Pneumatic Unit (PU-17) ST-42 RB-10 RU-20 RR-10 COMPLETE RR-20 SA-20 OPSU-6 CF-70 SA-21 CV-65 SA-02 SA-31 AlphaN-SPSU SA-10 CV-70 CV-50 SA-01 CV-55 U-RDU RU-21 SA-30 CF-60 TU-40 SA-51 CV-11 TS-01 Automated Tube Sorter TH-11 BT-50 Urine Sample Transportation Unit ST-11 TA-01 Automated Tube Archiver Urine Sample Transportation Unit ST-10 Urine Sample Transportation Unit ST-12

    Establishment Types

    Manufacture Medical Device